Home NDC 29300-313-22 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Product NDC 29300-313
Requested package NDC 29300-313-22
11-digit product format 293000313
Labeler code 29300
Product ID 29300-313_b8b5717a-d6bc-468a-a9ee-ca6b73a13c51
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA210507
Marketing category ANDA
Marketing start 2024-09-10
Substance CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 5; 120 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210507-001 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE / ORAL 2024-09-10 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 5 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 64O047KTOA Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014571 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 29300-313-22 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 2 in 1 CARTON TABLET, FILM COATED, EXTENDED RE 2 4 29300-313-24 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 4 in 1 CARTON TABLET, FILM COATED, EXTENDED RE 4 4 29300-313-61 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 6 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-313 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.] 4 Current NDC, 3 package rows 20240925_af18ca44-615e-48ef-b678-7a9ae02e0f2a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 29300-313-22 29300031322 2 BLISTER PACK in 1 CARTON (29300-313-22) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (29300-313-61) 2 blister pack 2025-01-01 No No Current